SUPPLY CHAIN ARTICLES

  • Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control

    Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.

  • The Expanding Patent Landscape For RNA-Based Therapeutics

    The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.

  • Defining The RNA Therapeutics Industry In 2023

    Four executives outline which industry challenges, strategic considerations, and opportunities should be top of mind as RNA therapeutics companies establish their to-do lists for 2023.

  • Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault

    What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.

  • Assessing Quality Of mRNA Vaccines: Key Considerations

    To address the need for standards for mRNA vaccines, the United States Pharmacopeia (USP) has convened vaccine experts to identify important quality attributes and to propose test methods that can be used to assess mRNA vaccine products. This article shares those CQAs and analytical procedure tips.

  • Moderna & The Global mRNA Supply Chain: Regulatory Lessons Learned

    One of the most important reminders I took away from Moderna’s experiences ushering its mRNA vaccine onto the global market is that a commercial manufacturing process must also be accompanied by a commercially ready supply chain. Though sufficient physical volumes of each raw material and a redundant supplier network are necessities, physical scale is not the only “CQA” for which we must account when commercializing our supply chain. 

SUPPLY CHAIN VIDEOS

Explore the broad benefits and challenges that could be encounter by working with self-amplifying and circular RNA modalities — particularly in terms of manufacturing, raw material supply, COGS, and patient centricity.

In this Bioprocess Online Live panel, we discuss the current state of the mRNA supply chain for critical raw materials and manufacturing supplies and where pain points still exist.

ALMAC expert Jill Caswell identifies the most overlooked challenges of working with ligase for the chemoenzymatic reaction, as well as the impact this is having today on enzyme engineering and purification. 

While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.

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